BRQ Documentation Specialist

Pfizer

Job Details

**ROLE SUMMARY**

The **BRQ Documentation Specialist** will support batch record storage in alignment with the document retention policy including off-site storage. The colleague will assist in the batch record archival process at the Rocky Mount site for commercially distributed products (domestic and international). The incumbent will ensure that each batch record has been cataloged, barcoded and archived appropriately.

The **BRQ Documentation Specialist** will support the collection of defect data from the 100% visual inspection process of commercial products manufactured at the Pfizer, Rocky Mount site.

The **BRQ Documentation Specialist** will also assist in the timely retrieval of requested records in support of investigations, inspections, PC1 and external requests. The colleague will ensure all removed records are returned and stored appropriately.

ROLE RESPONSIBILITIES

+ Responsible for the retrieval of visual inspection defect data from the accountability batch records/ABR system of each finished product batch post release.

+ Support batch record storage in alignment with the document retention policy, including off-site storage.

+ Ensure batch records for commercially distributed products (domestic and international) are stored and archived in accordance with Rocky Mount site requirements.

+ Ensures that each batch record has been cataloged, barcoded and archived appropriately.

+ Acquire batch record copies to support requests from site internal/external customers (PC1, Canada, etc.).

+ Supports and maintains an environment that fosters the Pfizer Own It culture within Batch Disposition and other departments.

Perform other duties as assigned by area management.

QUALIFICATIONS

The **BRQ Documentation Specialist** position requires demonstrated attention to detail and organizational skills. It is preferred the incumbent have an Associate's degree or a minimum of 4 years of experience working in a regulated industry (preferably in quality assurance or quality control). Must possess the basic knowledge of cGMPs and FDA requirements and be familiar with master formulas and batch records. Excellent organizational, interpersonal and communication skills (oral and written). Proven ability to work with minimum supervision. Working knowledge of mathematical concepts and a demonstrated proficiency in computerized systems.

**PHYSICAL/MENTAL REQUIREMENTS**

The **BRQ Documentation Specialist** position will requires lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis. The incumbent may be required stand up for periods of up to 4 hours, use a computer for up to 8 hours and walk up and down stairs.

**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

The **BRQ Documentation Specialist** position may require some overtime or weekend work to meet the department requirements as needed. The incumbent is required to adhere to all safety policies and procedures along with cGMP, regulatory requirements, internal Standard Operating Procedures (SOPs) and Pfizer policies and standards. Travel for this position is minimal to none.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.